7 to 10 years
Job Title: Senior Director, Bioassay Development and Animal Care
Job Description
Provide scientific, technical, and operational leadership for in vivo bioassay development and animal care. This role ensures regulatory compliance, drives continuous improvement, and supports site-wide initiatives through cross-functional collaboration. The manager is accountable for strategy, people development, and delivering scientifically sound, regulatory-aligned bioassay results that support global product quality and release.
Responsibilities
- Lead the development, qualification, and validation of in vivo and biological assays in alignment with global pharmacopeia (USP, EP, BP, ChP).
- Interpret bioassay statistics, including 2x2 and 3x3 parallel line models and non-linear regression to define dose-response relationships.
- Design and manage assay protocols using Excel and statistical software; author associated validation documentation.
- Review and trend assay performance to ensure data integrity and consistency.
- Ensure fitness-for-purpose of methods used for lot release and stability and proactively identify areas for method optimization.
- Maintain and update computer programs for statistical evaluation of assay data.
- Provide expertise in dose range selection, trending, and analysis.
- Coach and develop a multidisciplinary team of scientists, technicians, and animal care staff.
- Set goals, provide regular feedback, and manage performance and development plans.
- Foster a culture of scientific rigor, compliance, and ethical animal care.
- Champion cross-training and succession planning within the team.
- Ensure readiness and responsiveness to business and regulatory needs.
- Ensure adherence to regulatory requirements (FDA, DEA, USDA, IACUC) and global animal welfare standards.
- Oversee facility operations for bioassay and animal husbandry, ensuring GxP compliance.
- Lead and support regulatory inspections and internal/external audits.
- Implement and continuously improve SOPs, risk assessments, and CAPA responses to maintain inspection readiness.
- Oversee accurate documentation of animal use and support Global Bioassay Ethics Committee submissions.
- Align bioassay and animal care strategies with site and global business priorities.
- Collaborate with QA, Regulatory Affairs, and R&D to ensure end-to-end method lifecycle management.
- Recommend prioritization of projects and resources based on scientific complexity and business impact.
- Participate in site leadership forums and global scientific councils to influence direction and policy.
Essential Skills
- Bachelor’s degree in Biology, Pharmacology, Animal Science, or related field required; MS/PhD preferred.
- Minimum 7–10 years of experience in in vivo scientific or regulated pharmaceutical environments.
- Proven expertise in bioassay development, statistical modeling, and pharmacopeial standards.
- Demonstrated success in leading high-performing scientific teams in a regulated environment.
- Proficiency in Excel, GraphPad Prism, or other statistical software tools used for assay modeling.
- Strong communication skills with the ability to influence across levels and functions.
Additional Skills & Qualifications
- Work in laboratory and vivarium settings, including exposure to animals and biological materials.
- May involve standing for extended periods and lifting up to 30 lbs.
Work Environment
Working in a GMP lab. Occasional travel (up to 10%) may be required for audits, training, or collaboration with global teams. Creating a new lab and will be shadowing current research lab.
Job Type & LocationThis is a Permanent position based out of Parsippany, NJ.
Pay and BenefitsThe pay range for this position is $150000.00 - $160000.00/yr.
Will share specifics during the interview process. Will be getting holiday, and PTO packages.
Workplace TypeThis is a fully onsite position in Parsippany,NJ.
Application DeadlineThis position is anticipated to close on Jun 26, 2026.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
Posting ID: JP-006102950
